Only healthy volunteers are included in this trial. Alcohol-based hand rubs are licensed drugs in Germany. They are indicated to perform hand disinfection by health care workers and are used within this indication in this trial.
Conditions
Interventions
Trade Name: Softa-Man(R) acute
Product Name: Softa-Man(R) acute
Pharmaceutical Form: Cutaneous solution
INN or Proposed INN: ETHANOL (96 PER CENT)
CAS Number: 0
Other descriptive name: ETHANOL (96 PER
Sponsors
University Medical Center Freiburg
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: General inclusion criteria: # Signed informed consent of the volunteer # Person aged > 18 years # Person who are legally competent and able to sign Specific inclusion criteria: # Healthy volunteer (i. e. person who is not under medical care at the time of inclusion) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: General exclusion criteria: # Person who is not legally competent and able to sign or who do not understand the nature, intent and importance of the trial # Person who is participating in other interventional trial # Person who has participated in other interventional trial within the last 30 days before the start of this trial # Known alcohol- or nicotine abuse in history # Person who is dependent or employed by the sponsor or principal investigator For women: # Established or planned pregnancy, lactation Specific exclusion criteria: # Dermatosis of any origin, especially: # Hand eczema # Sunburn at the hands # Atopic dermatitis # Known sensitisation or allergy against one of the ingredients of the IMPs # Continuous contact to detergents or disinfectants or continuous moist work (occupation as health care worker, in gastronomy or as a cleaner).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Uncoated viruses such as adenovirus or norovirus are a challenge for infection control strategies since these pathogens are highly resistant to disinfectants. Hand hygiene is accepted to be an essential measure to prevent infections caused by adeno- or norovirus. In case of an adeno- or norovirus infection within the clinical setting it is strongly recommended to use a virucidal hand rub and to exchange conventional hand disinfectants by virucidal ones (German recommendation by the Robert Koch-Institute; www.rki.de). Disadvantage of virucidal hand rubs, however, might be limited skin-tolerability compared to conventional products. This in turn may impair hand hygiene compliance. The aim of this trial is to compare the tolerability of three different virucidal hand rubs and a reference conventional product. ;Secondary Objective: NA;Primary end point(s): # Transepidermal water loss (TEWL) before and after each 4-day intervention phase. The TEWL is a dimension to assess the skin's barrier function. | — |
Countries
Germany
Outcome results
None listed